125547orig1s000 - food and drug administration...product quality (biotechnology) filing review for...

CENTER FOR DRUG EVALUATION AND RESEARCH

APPLICATION NUMBER:

125547Orig1s000

CHEMISTRY REVIEW(S)

BLA STN 125547

PortrazzaTM (necitumumab)

Eli Lilly and Company

Ying-Xin Fan, Ph.D., Reviewer Yan Wang, Ph.D. , Reviewer

Ralph M. Bernstein, Ph.D., Reviewer Chana Fuchs, Ph.D., Team Lead

CDER/OPQ/OBP/DBRRIV

PRODUCT QUALITY (BIOTECHNOLOGY)FILING REVIEW FOR ORIGINAL BLA/NDA (OBP & DMPQ)

File Name: 5_Product_Quality (biotech) Filing Review (OBP & DMPQ) MMDDYY.doc Page 8

Please identify and list any potential review issues to be forwarded to the Applicant for the 74-day letter.

Not applicable

Lakshmi Narasimhan -A

Digitally signed by Lakshmi Narasimhan -A DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000640223, cn=Lakshmi Narasimhan -A Date: 2015.02.13 08:12:30 -05'00'

Candace Y. Gomez-broughton -S

Digitally signed by Candace Y. Gomez-broughton -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000640207, cn=Candace Y. Gomez-broughton -S Date: 2015.02.13 09:58:00 -05'00'

Patricia F. Hughestroost -S

Digitally signed by Patricia F. Hughestroost -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=1300096547, cn=Patricia F. Hughestroost -S Date: 2015.02.13 11:02:07 -05'00'

PRODUCT QUALITY (Biotechnology)FILING REVIEW FOR ORIGINAL BLA/NDA (OBP)

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IS THE PRODUCT QUALITY SECTION OF THE APPLICATION FILEABLE? Yes

If the application is not fileable from product quality perspective, state the reasons and provide comments to be sent to the Applicant.

Please identify and list any potential review issues to be forwarded to the Applicant for the 74-day letter.

Product Quality Reviewer(s) Date

Branch Chief/Team Leader/Supervisor Date

Division Director Date

Yunhua Jia -S

Digitally signed by Yunhua Jia -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Yunhua Jia -S, 0.9.2342.19200300.100.1.1=2000377236 Date: 2015.01.23 14:31:49 -05'00'

Chana Fuchs -SDigita ly signed by Chana Fuchs S DN: c=US o=U S Government ou=HHS ou=FDA ou=People cn=Chana Fuchs S 0 9 2342 19200300 100 1 1=2000601863 Date: 2015 01 23 14:47:12 05 00

PRODUCT QUALITY (Biotechnology)FILING REVIEW FOR ORIGINAL BLA/NDA (OBP)

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APPEARS THIS WAY ON ORIGINAL